Public Citizen’s main concern is that the HHS’ Office of Human Research Protections (OHRP) gave two universities involved in the research the green light to begin the trial even though – in the group’s view – the study does not satisfy the requirements of regulation 45 CFR Part 46 on consent.

It alleges that the OHRP’s conclusion the trial “presented the prospect of direct benefit to individual subjects and thus was approvable under HHS regulations,” is based on excerpts from the background section of the protocol and superficial assurances from University of Minnesota’s IRB.

“The evidence and rationale cited in OHRP’s letter to support the agency’s determinations are clearly flimsy and insufficient. More disturbing, OHRP’s explanation for its determinations reflects a stunning disregard for, and an apparent lack of understanding of, the very regulations that agency is charged with enforcing.

“More broadly, this OHRP decision reflects a continuing trend spanning several years during which the leadership of OHRP has failed to effectively implement the regulations for the protection of human subjects and has taken stances that place greater priority on protecting the interests of the HHS agencies, research institutions, and investigators than protecting the rights and welfare of human subjects.”

Public Citizen called on the HHS to halt the trial, ask the OHRP to reassess the protocol and produce a ‘robust, evidence-based rationale' for its decision.

The pressure group warned that allowing the current decision to stand “will seriously undermine the special regulatory protections for children involved in research.”

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